Cytoplast Titanium-Reinforced PTFE Membranes

Barrier, Synthetic, Intraoral

Osteogenics Biomedical, Inc.

The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Cytoplast Titanium-reinforced Ptfe Membranes.

Pre-market Notification Details

Device IDK201187
510k NumberK201187
Device Name:Cytoplast Titanium-Reinforced PTFE Membranes
ClassificationBarrier, Synthetic, Intraoral
Applicant Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock,  TX  79424
ContactShane Shuttlesworth
CorrespondentShane Shuttlesworth
Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock,  TX  79424
Product CodeNPK  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2021-01-23

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